Mangosteen juice blend for the reduction of inflammation in obese subjects

Completed

Conditions: Metabolic syndrome/obesity
Nutritional, Metabolic, Endocrine
Obesity

Registration Number: ISRCTN93000276

Lead Sponsor: XanGo, LLC (USA)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

1. Aged between 30 - 75 years of age, either sex
2. Body mass index (BMI) greater than 30 and less than 45 kg/m^2 (obese)
3. A high sensitivity C-reactive protein (HS-CRP) of greater than 3
4. Agreed to discontinue anti-inflammatory medications and supplements (other than daily 81 mg aspirin, which was allowed)
5. Agreed to use approved birth control methods if a female of childbearing age
6. Agreed to not initiate or change any exercise or diet programs during the study

Exclusion Criteria

1. Subjects were excluded if they had consumed the test product in the past
2. Had allergies to the test product
3. Using any drugs that can affect CRP
4. Were taking hormone replacements, anticoagulants or anti-platelet therapy
5. Had surgery in the past 6 months
6. Smoked cigarettes
7. Known alcohol or drug abuse
8. Had major systemic, inflammatory or chronic disease
9. Untreated depression
10. Active eating disorder
11. Unable to understand or follow study protocol
12. Pregnant or lactating
13. Any medical condition which, in the opinion of the investigator, might interfere with the subject's ability in the trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of multiple doses of XanGo™ Juice compared to placebo on inflammation as measured by levels of HS-CRP and cytokines (interleukin [IL]-1, IL-2, IL-4, IL-6, IL-7, IL-8, IL-10, IL-12, interferon (IFN)-gamma and tumour necrosis factor (TNF)-alpha). All outcomes measured at baseline, 4 weeks and 8 weeks.

Secondary Outcome Measures